This section discussed the environmental qualification data and established action/alert limits for a vaccine filling system housed within an isolator. A comparison is made to conventional clean room monitoring techniques and limits.

This presentation reviewed the physical and microbiological testing performed by Millipore on Steritest canisters following their exposure to hydorgen peroxide gas. The microbiological test results on new line of agar plates containing a sterilant neutralizer were also shared with the attendess.

This presentation reviews the principles of microbial monitoring in isolators, current US and European regulatory requirements for monitoring, and the means to achieve and maintain a germ free environment. The current means to monitor the air and surfaces in isolators is also touched upon.

This paper compares gamma-irradiation sterilized, modified DE Agar with standard non-irradiated D/E-Agar for recovery of organisms and capacity for neutralizing disinfecting agents. The neutralizing capacity was tested using 4 microorganisms (gram positive coccos, gram positive rod) with a wide range of disinfecting agents neutralized by D/E-Agar including aldehydes, phenol, quaternary agents, chlorine compounds, and hydrogen peroxide. The radiation-sterilized medium neutralized each disinfectant as well as the non-irradiated medium and fertility was equal or better on radiation sterilized DE Agar compared with standard D/E-Agar.